Aptiva® APS IgM Reagent
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Basic Information
- Primary DI
- 08430793040853
- Basic UDI-DI Code
- 843079304085345
- Reference
- 725140
- Device Types
-
Single use New device
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Inova Diagnostics. Inc.
Additional Description
The Aptiva APS IgM Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GPI) IgM autoantibodies in human serum and citrated plasma as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings. The Aptiva APS IgM Reagent is intended for use with the Aptiva Multi-Analyte System.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100503 | ANTI-B2-GLYCOPROTEIN I ANTIBODIES |
| W0102100501 | ANTI-CARDIOLIPIN ANTIBODIES |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).